Trial Outcomes & Findings for Comparative Efficacy of the Masquelet Versus Titanium Mesh Cage Techniques for the Treatment of Large Long Bone Defects (NCT NCT02015390)

Results Overview

Biplanar radiography to demonstrate adequate hardware placement and defect alignment in all patients in the Masquelet and Cage trial arms.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

2 weeks postop

Results posted on

2021-06-28

Participant Flow

There were 8 screen failures

Participant milestones

Participant milestones
Measure	Masquelet Defect Reconstruction The Masquelet defect reconstruction is a two-stage technique for the treatment of large segmental bone defects that involves the induction of a biomembrane using a poly(methylmethacrylate)(PMMA) cement spacer followed by cement removal and bone grafting of the defect while preserving the biomembrane. The biomembrane not only assists in retaining the bone graft, but serves as a rich source of vascular supply and growth factors which constitute an excellent biological milieu for the graft to consolidate and heal the defect. The first stage of the Masquelet defect reconstruction involves creating a biomembrane with a PMMA spacer; whereas the second stage performed 6-8 weeks later involves the spacer removal and packing the defect enclosed with the biomembrane with autogenous (RIA) or allogeneic bone graft. The biomembrane serves as a biological enclosure for the graft, provides vascular supply and growth factors, thereby creating an excellent milieu for the graft to consolidate.	Titanium Cage Reconstruction The cylindrical titanium mesh cage technique is a single-stage surgical procedure that immediately restores limb anatomy and alignment, and provides limb stability sufficient enough for early, unrestricted mobilization while permitting bone and soft tissue healing. It involves the implantation of a fenestrated cylindrical titanium mesh cage packed with autogenous bone graft (harvested using Reamer-Irrigator-Aspirator) or with allogeneic bone graft. After aseptic defect and soft tissue bed is achieved, the titanium cage reconstruction procedure involves the implantation of a fenestrated cylindrical titanium cage packed with simultaneously harvested autogenous bone graft using RIA or with allogeneic bone graft. The decision about the graft option is left for the treating physician, following the discussion with the patient. The cage provide a biomechanical enclosure for the graft, allows the graft to be loaded, and, thereby consolidate and heal the defect.
Overall Study STARTED	9	7
Overall Study COMPLETED	8	3
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Masquelet Defect Reconstruction The Masquelet defect reconstruction is a two-stage technique for the treatment of large segmental bone defects that involves the induction of a biomembrane using a poly(methylmethacrylate)(PMMA) cement spacer followed by cement removal and bone grafting of the defect while preserving the biomembrane. The biomembrane not only assists in retaining the bone graft, but serves as a rich source of vascular supply and growth factors which constitute an excellent biological milieu for the graft to consolidate and heal the defect. The first stage of the Masquelet defect reconstruction involves creating a biomembrane with a PMMA spacer; whereas the second stage performed 6-8 weeks later involves the spacer removal and packing the defect enclosed with the biomembrane with autogenous (RIA) or allogeneic bone graft. The biomembrane serves as a biological enclosure for the graft, provides vascular supply and growth factors, thereby creating an excellent milieu for the graft to consolidate.	Titanium Cage Reconstruction The cylindrical titanium mesh cage technique is a single-stage surgical procedure that immediately restores limb anatomy and alignment, and provides limb stability sufficient enough for early, unrestricted mobilization while permitting bone and soft tissue healing. It involves the implantation of a fenestrated cylindrical titanium mesh cage packed with autogenous bone graft (harvested using Reamer-Irrigator-Aspirator) or with allogeneic bone graft. After aseptic defect and soft tissue bed is achieved, the titanium cage reconstruction procedure involves the implantation of a fenestrated cylindrical titanium cage packed with simultaneously harvested autogenous bone graft using RIA or with allogeneic bone graft. The decision about the graft option is left for the treating physician, following the discussion with the patient. The cage provide a biomechanical enclosure for the graft, allows the graft to be loaded, and, thereby consolidate and heal the defect.
Overall Study Lost to Follow-up	1	0
Overall Study Adverse Event	0	3
Overall Study Physician Decision	0	1

Baseline Characteristics

Comparative Efficacy of the Masquelet Versus Titanium Mesh Cage Techniques for the Treatment of Large Long Bone Defects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Masquelet Defect Reconstruction n=9 Participants The Masquelet defect reconstruction is a two-stage technique for the treatment of large segmental bone defects that involves the induction of a biomembrane using a poly(methylmethacrylate)(PMMA) cement spacer followed by cement removal and bone grafting of the defect while preserving the biomembrane. The biomembrane not only assists in retaining the bone graft, but serves as a rich source of vascular supply and growth factors which constitute an excellent biological milieu for the graft to consolidate and heal the defect. The first stage of the Masquelet defect reconstruction involves creating a biomembrane with a PMMA spacer; whereas the second stage performed 6-8 weeks later involves the spacer removal and packing the defect enclosed with the biomembrane with autogenous (RIA) or allogeneic bone graft. The biomembrane serves as a biological enclosure for the graft, provides vascular supply and growth factors, thereby creating an excellent milieu for the graft to consolidate.	Titanium Cage Reconstruction n=7 Participants The cylindrical titanium mesh cage technique is a single-stage surgical procedure that immediately restores limb anatomy and alignment, and provides limb stability sufficient enough for early, unrestricted mobilization while permitting bone and soft tissue healing. It involves the implantation of a fenestrated cylindrical titanium mesh cage packed with autogenous bone graft (harvested using Reamer-Irrigator-Aspirator) or with allogeneic bone graft. After aseptic defect and soft tissue bed is achieved, the titanium cage reconstruction procedure involves the implantation of a fenestrated cylindrical titanium cage packed with simultaneously harvested autogenous bone graft using RIA or with allogeneic bone graft. The decision about the graft option is left for the treating physician, following the discussion with the patient. The cage provide a biomechanical enclosure for the graft, allows the graft to be loaded, and, thereby consolidate and heal the defect.	Total n=16 Participants Total of all reporting groups
Age, Continuous	53.56 years n=5 Participants	46.43 years n=7 Participants	50.43 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks postop

Population: 2 week radiographic imaging

Biplanar radiography to demonstrate adequate hardware placement and defect alignment in all patients in the Masquelet and Cage trial arms.

Outcome measures

Outcome measures
Measure	Masquelet Defect Reconstruction n=9 Participants The Masquelet defect reconstruction is a two-stage technique for the treatment of large segmental bone defects that involves the induction of a biomembrane using a poly(methylmethacrylate)(PMMA) cement spacer followed by cement removal and bone grafting of the defect while preserving the biomembrane. The biomembrane not only assists in retaining the bone graft, but serves as a rich source of vascular supply and growth factors which constitute an excellent biological milieu for the graft to consolidate and heal the defect. The first stage of the Masquelet defect reconstruction involves creating a biomembrane with a PMMA spacer; whereas the second stage performed 6-8 weeks later involves the spacer removal and packing the defect enclosed with the biomembrane with autogenous (RIA) or allogeneic bone graft. The biomembrane serves as a biological enclosure for the graft, provides vascular supply and growth factors, thereby creating an excellent milieu for the graft to consolidate.	Titanium Cage Reconstruction n=7 Participants The cylindrical titanium mesh cage technique is a single-stage surgical procedure that immediately restores limb anatomy and alignment, and provides limb stability sufficient enough for early, unrestricted mobilization while permitting bone and soft tissue healing. It involves the implantation of a fenestrated cylindrical titanium mesh cage packed with autogenous bone graft (harvested using Reamer-Irrigator-Aspirator) or with allogeneic bone graft. After aseptic defect and soft tissue bed is achieved, the titanium cage reconstruction procedure involves the implantation of a fenestrated cylindrical titanium cage packed with simultaneously harvested autogenous bone graft using RIA or with allogeneic bone graft. The decision about the graft option is left for the treating physician, following the discussion with the patient. The cage provide a biomechanical enclosure for the graft, allows the graft to be loaded, and, thereby consolidate and heal the defect.
Number of Participants With Defect Healing - Plain Radiography	9 Participants	7 Participants

PRIMARY outcome

Timeframe: 6 weeks postop

Population: 6 week radiographic imaging

Biplanar radiography to demonstrate defect and graft alignment in all patients in the Masquelet and Cage trial arms.

Outcome measures

Outcome measures
Measure	Masquelet Defect Reconstruction n=9 Participants The Masquelet defect reconstruction is a two-stage technique for the treatment of large segmental bone defects that involves the induction of a biomembrane using a poly(methylmethacrylate)(PMMA) cement spacer followed by cement removal and bone grafting of the defect while preserving the biomembrane. The biomembrane not only assists in retaining the bone graft, but serves as a rich source of vascular supply and growth factors which constitute an excellent biological milieu for the graft to consolidate and heal the defect. The first stage of the Masquelet defect reconstruction involves creating a biomembrane with a PMMA spacer; whereas the second stage performed 6-8 weeks later involves the spacer removal and packing the defect enclosed with the biomembrane with autogenous (RIA) or allogeneic bone graft. The biomembrane serves as a biological enclosure for the graft, provides vascular supply and growth factors, thereby creating an excellent milieu for the graft to consolidate.	Titanium Cage Reconstruction n=3 Participants The cylindrical titanium mesh cage technique is a single-stage surgical procedure that immediately restores limb anatomy and alignment, and provides limb stability sufficient enough for early, unrestricted mobilization while permitting bone and soft tissue healing. It involves the implantation of a fenestrated cylindrical titanium mesh cage packed with autogenous bone graft (harvested using Reamer-Irrigator-Aspirator) or with allogeneic bone graft. After aseptic defect and soft tissue bed is achieved, the titanium cage reconstruction procedure involves the implantation of a fenestrated cylindrical titanium cage packed with simultaneously harvested autogenous bone graft using RIA or with allogeneic bone graft. The decision about the graft option is left for the treating physician, following the discussion with the patient. The cage provide a biomechanical enclosure for the graft, allows the graft to be loaded, and, thereby consolidate and heal the defect.
Number of Participants With Defect Healing - Plain Radiography	9 Participants	3 Participants

PRIMARY outcome

Timeframe: 3 months postop

Population: 3 month radiographic imaging

Radiographic assessment to demonstrate the adequate bony alignment and hardware placements for all patients in the Masquelet and Cage trial arms maintained upon patients' active weightbearing.

Outcome measures

Outcome measures
Measure	Masquelet Defect Reconstruction n=8 Participants The Masquelet defect reconstruction is a two-stage technique for the treatment of large segmental bone defects that involves the induction of a biomembrane using a poly(methylmethacrylate)(PMMA) cement spacer followed by cement removal and bone grafting of the defect while preserving the biomembrane. The biomembrane not only assists in retaining the bone graft, but serves as a rich source of vascular supply and growth factors which constitute an excellent biological milieu for the graft to consolidate and heal the defect. The first stage of the Masquelet defect reconstruction involves creating a biomembrane with a PMMA spacer; whereas the second stage performed 6-8 weeks later involves the spacer removal and packing the defect enclosed with the biomembrane with autogenous (RIA) or allogeneic bone graft. The biomembrane serves as a biological enclosure for the graft, provides vascular supply and growth factors, thereby creating an excellent milieu for the graft to consolidate.	Titanium Cage Reconstruction n=3 Participants The cylindrical titanium mesh cage technique is a single-stage surgical procedure that immediately restores limb anatomy and alignment, and provides limb stability sufficient enough for early, unrestricted mobilization while permitting bone and soft tissue healing. It involves the implantation of a fenestrated cylindrical titanium mesh cage packed with autogenous bone graft (harvested using Reamer-Irrigator-Aspirator) or with allogeneic bone graft. After aseptic defect and soft tissue bed is achieved, the titanium cage reconstruction procedure involves the implantation of a fenestrated cylindrical titanium cage packed with simultaneously harvested autogenous bone graft using RIA or with allogeneic bone graft. The decision about the graft option is left for the treating physician, following the discussion with the patient. The cage provide a biomechanical enclosure for the graft, allows the graft to be loaded, and, thereby consolidate and heal the defect.
Number of Participants With Defect Healing - Plain Radiography	8 Participants	3 Participants

PRIMARY outcome

Timeframe: 6 months postop

Population: 6 month radiographic imaging

Radiographic biplanar determination of bone defect healing progression.

Outcome measures

Outcome measures
Measure	Masquelet Defect Reconstruction n=8 Participants The Masquelet defect reconstruction is a two-stage technique for the treatment of large segmental bone defects that involves the induction of a biomembrane using a poly(methylmethacrylate)(PMMA) cement spacer followed by cement removal and bone grafting of the defect while preserving the biomembrane. The biomembrane not only assists in retaining the bone graft, but serves as a rich source of vascular supply and growth factors which constitute an excellent biological milieu for the graft to consolidate and heal the defect. The first stage of the Masquelet defect reconstruction involves creating a biomembrane with a PMMA spacer; whereas the second stage performed 6-8 weeks later involves the spacer removal and packing the defect enclosed with the biomembrane with autogenous (RIA) or allogeneic bone graft. The biomembrane serves as a biological enclosure for the graft, provides vascular supply and growth factors, thereby creating an excellent milieu for the graft to consolidate.	Titanium Cage Reconstruction n=3 Participants The cylindrical titanium mesh cage technique is a single-stage surgical procedure that immediately restores limb anatomy and alignment, and provides limb stability sufficient enough for early, unrestricted mobilization while permitting bone and soft tissue healing. It involves the implantation of a fenestrated cylindrical titanium mesh cage packed with autogenous bone graft (harvested using Reamer-Irrigator-Aspirator) or with allogeneic bone graft. After aseptic defect and soft tissue bed is achieved, the titanium cage reconstruction procedure involves the implantation of a fenestrated cylindrical titanium cage packed with simultaneously harvested autogenous bone graft using RIA or with allogeneic bone graft. The decision about the graft option is left for the treating physician, following the discussion with the patient. The cage provide a biomechanical enclosure for the graft, allows the graft to be loaded, and, thereby consolidate and heal the defect.
Number of Participants With Defect Healing - Plain Radiography	8 Participants	3 Participants

PRIMARY outcome

Timeframe: 12 months postop

Population: 12 month radiographic imaging

Radiographic imaging to demonstrate bone graft consolidation and callus formation in the patients with the Masquelet reconstruction and cage techniques.

Outcome measures

Outcome measures
Measure	Masquelet Defect Reconstruction n=8 Participants The Masquelet defect reconstruction is a two-stage technique for the treatment of large segmental bone defects that involves the induction of a biomembrane using a poly(methylmethacrylate)(PMMA) cement spacer followed by cement removal and bone grafting of the defect while preserving the biomembrane. The biomembrane not only assists in retaining the bone graft, but serves as a rich source of vascular supply and growth factors which constitute an excellent biological milieu for the graft to consolidate and heal the defect. The first stage of the Masquelet defect reconstruction involves creating a biomembrane with a PMMA spacer; whereas the second stage performed 6-8 weeks later involves the spacer removal and packing the defect enclosed with the biomembrane with autogenous (RIA) or allogeneic bone graft. The biomembrane serves as a biological enclosure for the graft, provides vascular supply and growth factors, thereby creating an excellent milieu for the graft to consolidate.	Titanium Cage Reconstruction n=3 Participants The cylindrical titanium mesh cage technique is a single-stage surgical procedure that immediately restores limb anatomy and alignment, and provides limb stability sufficient enough for early, unrestricted mobilization while permitting bone and soft tissue healing. It involves the implantation of a fenestrated cylindrical titanium mesh cage packed with autogenous bone graft (harvested using Reamer-Irrigator-Aspirator) or with allogeneic bone graft. After aseptic defect and soft tissue bed is achieved, the titanium cage reconstruction procedure involves the implantation of a fenestrated cylindrical titanium cage packed with simultaneously harvested autogenous bone graft using RIA or with allogeneic bone graft. The decision about the graft option is left for the treating physician, following the discussion with the patient. The cage provide a biomechanical enclosure for the graft, allows the graft to be loaded, and, thereby consolidate and heal the defect.
Number of Participants With Defect Healing - Plain Radiography	8 Participants	3 Participants

PRIMARY outcome

Timeframe: 18 months postop

Population: 18 month radiographic imaging

Radiographic biplanar determination of bone defect healing to demonstrate bone graft consolidation and defect healing in all Masquelet- and Cage-treated patients who completed the trial.

Outcome measures

Outcome measures
Measure	Masquelet Defect Reconstruction n=8 Participants The Masquelet defect reconstruction is a two-stage technique for the treatment of large segmental bone defects that involves the induction of a biomembrane using a poly(methylmethacrylate)(PMMA) cement spacer followed by cement removal and bone grafting of the defect while preserving the biomembrane. The biomembrane not only assists in retaining the bone graft, but serves as a rich source of vascular supply and growth factors which constitute an excellent biological milieu for the graft to consolidate and heal the defect. The first stage of the Masquelet defect reconstruction involves creating a biomembrane with a PMMA spacer; whereas the second stage performed 6-8 weeks later involves the spacer removal and packing the defect enclosed with the biomembrane with autogenous (RIA) or allogeneic bone graft. The biomembrane serves as a biological enclosure for the graft, provides vascular supply and growth factors, thereby creating an excellent milieu for the graft to consolidate.	Titanium Cage Reconstruction n=3 Participants The cylindrical titanium mesh cage technique is a single-stage surgical procedure that immediately restores limb anatomy and alignment, and provides limb stability sufficient enough for early, unrestricted mobilization while permitting bone and soft tissue healing. It involves the implantation of a fenestrated cylindrical titanium mesh cage packed with autogenous bone graft (harvested using Reamer-Irrigator-Aspirator) or with allogeneic bone graft. After aseptic defect and soft tissue bed is achieved, the titanium cage reconstruction procedure involves the implantation of a fenestrated cylindrical titanium cage packed with simultaneously harvested autogenous bone graft using RIA or with allogeneic bone graft. The decision about the graft option is left for the treating physician, following the discussion with the patient. The cage provide a biomechanical enclosure for the graft, allows the graft to be loaded, and, thereby consolidate and heal the defect.
Number of Participants With Defect Healing - Plain Radiography	8 Participants	3 Participants

PRIMARY outcome

Timeframe: 12 months postop

Population: 12 month CT imaging

Radiographic spatial determination of bone defect healing

Outcome measures

Outcome measures
Measure	Masquelet Defect Reconstruction n=8 Participants The Masquelet defect reconstruction is a two-stage technique for the treatment of large segmental bone defects that involves the induction of a biomembrane using a poly(methylmethacrylate)(PMMA) cement spacer followed by cement removal and bone grafting of the defect while preserving the biomembrane. The biomembrane not only assists in retaining the bone graft, but serves as a rich source of vascular supply and growth factors which constitute an excellent biological milieu for the graft to consolidate and heal the defect. The first stage of the Masquelet defect reconstruction involves creating a biomembrane with a PMMA spacer; whereas the second stage performed 6-8 weeks later involves the spacer removal and packing the defect enclosed with the biomembrane with autogenous (RIA) or allogeneic bone graft. The biomembrane serves as a biological enclosure for the graft, provides vascular supply and growth factors, thereby creating an excellent milieu for the graft to consolidate.	Titanium Cage Reconstruction n=3 Participants The cylindrical titanium mesh cage technique is a single-stage surgical procedure that immediately restores limb anatomy and alignment, and provides limb stability sufficient enough for early, unrestricted mobilization while permitting bone and soft tissue healing. It involves the implantation of a fenestrated cylindrical titanium mesh cage packed with autogenous bone graft (harvested using Reamer-Irrigator-Aspirator) or with allogeneic bone graft. After aseptic defect and soft tissue bed is achieved, the titanium cage reconstruction procedure involves the implantation of a fenestrated cylindrical titanium cage packed with simultaneously harvested autogenous bone graft using RIA or with allogeneic bone graft. The decision about the graft option is left for the treating physician, following the discussion with the patient. The cage provide a biomechanical enclosure for the graft, allows the graft to be loaded, and, thereby consolidate and heal the defect.
Number of Participants With Defect Healing - Computed Tomography	8 Participants	3 Participants

PRIMARY outcome

Timeframe: 18 months postop

Population: 18 month CT imaging

Radiographic spatial determination of bone defect healing

Outcome measures

Outcome measures
Measure	Masquelet Defect Reconstruction n=8 Participants The Masquelet defect reconstruction is a two-stage technique for the treatment of large segmental bone defects that involves the induction of a biomembrane using a poly(methylmethacrylate)(PMMA) cement spacer followed by cement removal and bone grafting of the defect while preserving the biomembrane. The biomembrane not only assists in retaining the bone graft, but serves as a rich source of vascular supply and growth factors which constitute an excellent biological milieu for the graft to consolidate and heal the defect. The first stage of the Masquelet defect reconstruction involves creating a biomembrane with a PMMA spacer; whereas the second stage performed 6-8 weeks later involves the spacer removal and packing the defect enclosed with the biomembrane with autogenous (RIA) or allogeneic bone graft. The biomembrane serves as a biological enclosure for the graft, provides vascular supply and growth factors, thereby creating an excellent milieu for the graft to consolidate.	Titanium Cage Reconstruction n=3 Participants The cylindrical titanium mesh cage technique is a single-stage surgical procedure that immediately restores limb anatomy and alignment, and provides limb stability sufficient enough for early, unrestricted mobilization while permitting bone and soft tissue healing. It involves the implantation of a fenestrated cylindrical titanium mesh cage packed with autogenous bone graft (harvested using Reamer-Irrigator-Aspirator) or with allogeneic bone graft. After aseptic defect and soft tissue bed is achieved, the titanium cage reconstruction procedure involves the implantation of a fenestrated cylindrical titanium cage packed with simultaneously harvested autogenous bone graft using RIA or with allogeneic bone graft. The decision about the graft option is left for the treating physician, following the discussion with the patient. The cage provide a biomechanical enclosure for the graft, allows the graft to be loaded, and, thereby consolidate and heal the defect.
Number of Participants With Defect Healing - Computed Tomography	8 Participants	3 Participants

SECONDARY outcome

Timeframe: 2 weeks postop

Brief Pain Inventory

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks postop

Brief Pain Inventory

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months postop

Brief Pain Inventory

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months postop

The patients in both the Masquelet and Cage trial arms demonstrated most significant improvement in Brief Pain Inventory scores at 12 month followup. No statistical differences were observed in pain score among the patients from both trial arms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months postop

The trial patients in both Masquelet and Cage arms demonstrated continued improvements in pains score at 12 months followup. No significant difference in pains core were noted between the trial arms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months postop

Brief Pain Inventory

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks postop

Short-Form 36

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks postop

Short-Form 36

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months postop

Short-Form 36

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months postop

Short-Form 36

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months postop

Short-Form 36

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months postop

Among patients who completed the trial for both the Masquelet and Cage arms, SF-36 demonstrated an overall progressive improvement in the score comportment, such as in Physical function (PF); Mental health (MH); Social function (SC); Bodily pain (BP); Change in health (CH); Vitality (VT); Role limitation - physical (RLP); Role limitation - mental (RLM); Health perception (HP). The most apparent improvements were observed in the Physical function (PF); Mental health (MH); Social function (SC); Bodily pain (BP); Change in health (CH); Vitality (VT) and Health perception (HP). No statistical difference were noted in overall SF-36 scores between the trail arms.