Amniotic Membrane Wrapping and Tenolysis Versus Tenolysis Alone for Treatment of Tendon Adhesions of the Hand/Wrist

NCT ID: NCT03013582

Last Updated: 2017-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31

Brief Summary

Tendon adhesions of the hand remain a ubiquitous problem facing hand surgeons and hand therapists alike. Despite their commonality, no consensus exists as to the best means of preventing adhesions, or the most ideal methods to treat them once they have occurred. The purpose of this study is to compare patient outcomes after standard operative tenolysis performed for adhesions of the hand to outcomes after tenolysis with the use of allograft human amniotic membrane.

Detailed Description

Patients who are scheduled to undergo operative tenolysis of the flexor and/or extensor tendons of the hand will be recruited. Our target enrollment is 40 patients (20 control plus 20 experimental), based on the power analysis detailed in the next paragraph. Enrolled patients will be randomized to either standard operative tenolysis, or tenolysis with placement of AlloWrap. Randomization will be performed by computerized random number generator. All surgeries will be performed by one senior fellowship-trained hand surgeon. Baseline measurements of total active motion (TAM), passive range of motion (PROM), and survey scores of the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) and Patient Rated Wrist Evaluation (PRWE) will be recorded pre-operatively. In addition, patients' pain level will be assessed using the visual analog scale (VAS) both at rest, and during the examination. These same values will be re-evaluated at post-operative follow-up visits at 2 weeks, 1 month, 3 months and 6 months. PROM will also be evaluated intra-operatively by the surgeon, and documented.

Conditions

Tendinopathy; Adhesions Nos Postoperative; Scar; Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Amnion wrapping + Tenolysis

Standard surgical tenolysis + wrapping of the released tendon with amnion.

Group Type: EXPERIMENTAL

Amnion Tendon Wrapping

Intervention Type: BIOLOGICAL

Tendon is wrapped with the allograft

Surgical Tenolysis

Intervention Type: PROCEDURE

Surgical release of peritendinous scarred tissue

Tenolysis control

Standard surgical tenolysis alone

Group Type: PLACEBO_COMPARATOR

Surgical Tenolysis

Intervention Type: PROCEDURE

Surgical release of peritendinous scarred tissue

Interventions

Amnion Tendon Wrapping

Tendon is wrapped with the allograft

Intervention Type: BIOLOGICAL

Surgical Tenolysis

Surgical release of peritendinous scarred tissue

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• All adult patients deemed candidates for operative tenolysis of the hand or wrist
• Age ≥18

Exclusion Criteria

• Patients younger than 18 years at the time of surgery;
• Any patient who would not be able or willing to comply with the protocol or perform assessments;
• Patients with medical conditions that may preclude placement of human biological membrane;
• Patients who have previously undergone tenolysis on the operative hand;
• Patients that will have multiple surgeries that are deemed as possible confounders, particularly those requiring an additional incision;
• Is physically or mentally compromised (i.e. being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his or her ability to participate in the clinical study;
• Is a prisoner;
• Is a transient.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Randall W Culp, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University-Philadelphia Hand Center

Michael P Gaspar, MD

Role: STUDY_DIRECTOR

Thomas Jefferson University-Philadelphia Hand Center

Central Contacts

Michael P Gaspar, MD

Role: CONTACT

michaelpgaspar@gmail.com

References

Vucekovich K, Gallardo G, Fiala K. Rehabilitation after flexor tendon repair, reconstruction, and tenolysis. Hand Clin. 2005 May;21(2):257-65. doi: 10.1016/j.hcl.2004.11.006.

Reference Type: BACKGROUND

PMID: 15882604 (View on PubMed)

Rouhani A, Tabrizi A, Ghavidel E. Effects of non-steroidal anti-inflammatory drugs on flexor tendon rehabilitation after repair. Arch Bone Jt Surg. 2013 Sep;1(1):28-30. Epub 2013 Sep 15.

Reference Type: BACKGROUND

PMID: 25207280 (View on PubMed)

Kohanzadeh S, Lugo L, Long JN. Safety of antiadhesion barriers in hand surgery. Ann Plast Surg. 2013 May;70(5):527-9. doi: 10.1097/SAP.0b013e31827eace2.

Reference Type: BACKGROUND

PMID: 23542850 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 24560801 (View on PubMed)

Wu YF, Tang JB. Apoptosis in adhesions and the adhesion-tendon gliding interface: relationship to adhesion-tendon gliding mechanics. J Hand Surg Am. 2013 Jun;38(6):1071-8. doi: 10.1016/j.jhsa.2013.03.012. Epub 2013 May 6.

Reference Type: BACKGROUND

PMID: 23660197 (View on PubMed)

Ozboluk S, Ozkan Y, Ozturk A, Gul N, Ozdemir RM, Yanik K. The effects of human amniotic membrane and periosteal autograft on tendon healing: experimental study in rabbits. J Hand Surg Eur Vol. 2010 May;35(4):262-8. doi: 10.1177/1753193409337961. Epub 2009 Aug 17.

Reference Type: BACKGROUND

PMID: 19687075 (View on PubMed)

Branford OA, Lee DA, Bader DL, Grobbelaar AO. The mechanics of flexor tendon adhesions. J Hand Surg Eur Vol. 2012 Jul;37(6):555-63. doi: 10.1177/1753193411432675. Epub 2011 Dec 14.

Reference Type: BACKGROUND

PMID: 22170243 (View on PubMed)

Gaspar MP, Abdelfattah HM, Welch IW, Vosbikian MM, Kane PM, Rekant MS. Recurrent cubital tunnel syndrome treated with revision neurolysis and amniotic membrane nerve wrapping. J Shoulder Elbow Surg. 2016 Dec;25(12):2057-2065. doi: 10.1016/j.jse.2016.09.013. Epub 2016 Oct 14.

Reference Type: BACKGROUND

PMID: 27751716 (View on PubMed)

Other Identifiers

16D.538

Identifier Type: -

Identifier Source: org_study_id