Passive Mobilization With Place and Hold Versus Active Motion Therapy After Flexor Tendon Repair: 5-year Minimum Follow-up of A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Range of motion
研究概览
简要总结
The aim of this study is to investigate if active mobilisation after flexor tendon repair in fingers gives better range of motion, strength, risk of rupture and patient satisfaction compared with passive mobilisation with place and hold after flexor tenon repair.
详细描述
Patients with an injury in flexor digitorum profundus (FDP) are eligible for inclusion in this study. The patients are referred to the Department of Hand Surgery at Sahlgrenska University Hospital. Potential patients are informed about the study. An informed consent is obtained from those who accept to participate. The surgery is performed in the same way for all patients with a four-stranded core suture and an epitendinous suture. The randomisation is performed after surgery when the patient is starting up rehabilitation 1-3 days after surgery. The randomisation was done by a computer program and the two different mobilisation protocols are placed accordingly in sealed envelopes numbered from 1 to 64. The envelopes are used one after another in a consecutive order.
All the operations are done by specialists in hand surgery or experienced residents in hand surgery at the clinic. The FDP tendon is repaired with a four-stranded core suture with a 4-0 Ti-cron (nonabsorbable braided polyester) and a running epitendinous suture according to Silfverskiöld with a 6-0 Prolene (nonabsorbable monofil polypropylene). Any concomitant injury in the flexor digitorum superficialis (FDS) tendon is repaired according to the surgeons preference. Any digital nerve is repaired with microsurgical instruments and a 8-0 or 9-0 S&T (non-absorbable polyamide monofilament).
Mobilisation
1-3 days after surgery the patient will be randomised to either active mobilisation or passive mobilisation with rubber bands and active place-and-hold at the hand rehabilitation unit in our clinic. The patients in both groups are closely followed by an occupational therapist for 12 weeks. Additional follow-up appointments are planned after 6 and 12 months. Patients in both groups are allowed to do all kinds of normal activity after 3 months and heavy manual work and gym training after 4 months.
Active mobilisation The active mobilisation program is based on the two programs, Belfast (ref) and Billericay (ref). Our program is a mix between these two. On the first day of mobilisation (1-3 days after surgery) the dressings are changed and a dorsal splint with the wrist in neutral position and the metacarpophalangeal (MCP) joints in 60-80 degrees of flexion is made for the patient. Another removable volar plate keeping the fingers extended is used in addition to the dorsal splint between training sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The occupational therapist who do the evaluation and make all the measurements 6 and 12 months after surgery don't know if the patient was randomised to active or passive mobilisation. Likewise the hand surgeon who do all the measurements at minimum 5 years after surgery don't know which rehabilitation protocol the patient followed.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary, complete injury to FDP in digit II-V
- •Injury in zone I och II
- •Operation within 72 hours from injury
- •The patient must be able to fulfill the rehabilitation program.
排除标准
- •Concomitant fracture
- •Concomitant soft tissue defect
- •Severe crush injury
- •Palmar plate injury demanding immobilisation
- •Concomitant joint injury
- •Concomitant extensor tendon injury
- •Bilateral injury
- •Previous loss of function in the finger before the injury
- •Uncertainty if the patient can fulfill the rehabilitation
- •The surgeon think it is unsuitable with active training after surgery
- •Concomitant injury of the flexor digitorum superficialis (FDS) or a digital nerve is accepted. A distal injury in zone I is not included if it requires a reinsertion of the tendon to the bone.
结局指标
主要结局
Range of motion
时间窗: Up to minimum 5 years after surgery
Range of motion in the proximal and distal interphalangeal joints in the injured finger and corresponding finger in the other hand are measured after 4, 8 and 12 weeks and after 6 and 12 months and minimum 5 years after surgery. We are interested to learn if there is a difference in range of motion between the two study groups.
次要结局
- Jamar grip strength(Up to minimum 5 years after surgery)
- Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure questionaire(Up to minimum 5 years after surgery)
- Key Pinch strength(Up to minimum 5 years after surgery)
- Tendon rerupture(Up to minimum 5 years after surgery)
- Need of secondary operation(Up to minimum 5 years after surgery)
研究者
Sara Chevalley
Specialist in Hand Surgery
Sahlgrenska University Hospital, Sweden